Bodily fluid sampling systems, methods, and devices

ABSTRACT

A fluid sampling system is disclosed comprising a fluid drawing device, a fluid sampling device, and an analysis device. The fluid drawing device can be used to draw bodily fluid into a sample port of an IV tube. The fluid sampling device can be used to access the sample port to obtain a fluid sample. The fluid sampling device can include a test strip housing for receiving a test strip therein. Extending from an end of the test strip housing is a blunt canula that can be inserted into the sample port to obtain the fluid sample and communicate the fluid sample to the test strip. The test strip housing is configured to allow the second end of the test strip to be received within an analysis device to facilitate analysis of the fluid sample.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 12/036,787, filed Feb. 25, 2008, entitled SYSTEMS, METHODS, ANDDEVICES FOR SAMPLING BODILY FLUID, which is a continuation-in-part ofU.S. patent application Ser. No. 11/765,888, filed Jun. 20, 2007,entitled SYSTEMS, METHODS, AND DEVICES FOR SAMPLING BODILY FLUID, whichclaims the benefit of U.S. Provisional Application No. 60/805,426, filedJun. 21, 2006, entitled BLOOD SAMPLING SYSTEM, all of which are herebyincorporated by reference in their entireties.

BACKGROUND

1. Technical Field

The invention relates to medical systems, methods, and devices. Morespecifically, the invention relates to systems, methods, and devices forsampling bodily fluid.

2. Relevant Technology

In some medical procedures, the condition of a patient can require thatan intravenous/intra-arterial tube or catheter be inserted into a bloodvessel. The patient's blood vessel can be connected by the tube to asource of fluid, such as a medicament. The tube can also be connected toa pressure transducer that senses the pressure within the patient'sblood vessel.

In critical care situations, it can be necessary to periodically obtainsamples of the patient's bodily fluids, such as blood. For procedurescarried out using a needle stick, the likelihood of a healthcare workerbeing inadvertently stuck can increase, thereby increasing the risk ofinfection from a contaminated needle. Rather than stick a patient with aneedle each time blood must be drawn, blood can be drawn through thetube already connected to the patient's blood vessel. Since the tubeconnected to the patient's blood vessel can contain fluid other thanblood, such as saline solution and medication, it is useful to draw thepatient's blood up into the tube to a sample site so that a blood samplecan be obtained which is substantially unadulterated by the fluid thatis being supplied to patient through the tube. After the substantiallyunadulterated blood has been drawn up the tube to the sampling site, theblood sample can be accessed through the sampling site and collectedinto a sample container.

In 2001, a study of 1548 patients was performed to demonstrate theeffects of “intensive insulin therapy” on mortality and morbidity. SeeGreet Van den Bergh, et. al., Intensive Insulin Therapy in CriticallyIll Patients, The New England Journal of Medicine, Vol. 345:1359-1367,No. 19, Nov. 8, 2001. The study showed that patients with tightlycontrolled blood glucose levels (between 80-110 mg/dl) had remarkablyimproved outcomes. Overall mortality was decreased by 34%, blood streaminfections decreased by 46%, acute renal failure requiring dialysis orhemofiltration decreased by 41%, and the median number of red celltransfusions decreased by 50% as well as requiring less time on theventilator and fewer days in the ICU.

The medical community has been striving for successful implementation ofintensive insulin therapy because of its documented benefits. In orderto implement this therapy, patients may have their fingers stuck forglucose readings every hour for days, weeks and even months. This cancause a significant amount of pain and torment to be inflicted on thepatients. Additionally, the costs associated with repeated glucose levelmonitoring, in both dollars and nursing time, can be considerable.

For example, in a 2006 study of a level 1 trauma center, the timerequired to measure blood glucose levels and adjust insulin dosesaccordingly ranged from three to eight minutes, with an average timenearing five minutes. See Aragon, Evaluation of Nursing Work Effort andPerceptions About Blood Glucose Testing in Tight Glycemic Control,American Journal of Critical Care, Vol. 15:370-377, No. 4, Jul. 2006.Based upon this average time as well as the average compensation fornurses, the study determined that a hospital's annual nursing cost forintensive insulin therapy is about $182,488. The study also found thatabout 75% of nurses use an arterial catheter to obtain the blood sampleswhile about 25% of nurses used finger sticks to obtain the needed bloodsamples. Using these proportions and the supply costs for each method,including lancets, syringes, and test strips, the study found that ahospital's annual supply cost for intensive insulin therapy is about$50,670.

In addition to the time and financial costs associated with intensiveinsulin therapy, the study also found that nurses feel that the currenttesting methods are difficult and require too much work. As a resultsome nurses try to keep their patients off intravenous insulin if at allpossible, despite the documented benefits. A large majority of thenurses surveyed, 86%, indicated that an easier or more automated form ofmeasurement was needed, while 76% indicated that they would be willingto devote an intravenous access for that purpose.

The subject matter claimed herein is not limited to embodiments thatsolve any disadvantages or that operate only in environments such asthose described above. Rather, this background is only provided toillustrate one exemplary technology area where some embodimentsdescribed herein may be practiced.

BRIEF SUMMARY

Example embodiments of the medical system described herein can enablethe user more freedom to deal with positional lines, obtain glucosereadings and can save time by initiating the testing process. Thissystem can accomplish various significant improvements over the currenttesting methods while still garnering the significant benefits ofintensive insulin therapy and being adaptable for use in nearly allhospitals. One benefit of the present invention is that it can reducepain and discomfort of patients by reducing repeated finger pricking andvenous sticks to obtain lab samples. Further, the present invention candecrease the time necessary for practitioners to ascertain a patient'sglucose levels and obtain blood samples for lab use. Another benefit ofthe present invention is that it can decrease the risk to practitionersand patients by reducing the need for needles used in the transfer ofblood from sample ports to test strips, and those used with phlebotomy.Additionally, the present invention can decrease cross contaminationrisk by utilizing a contained blood sample within the sampling device.

Embodiments of the present invention described herein relate to a fluidsampling system. The fluid sampling system can include a fluid drawingdevice, a fluid sampling device, and a glucometer to analyze the fluidsample. The fluid drawing device of the fluid sampling system can beused to draw bodily fluid, such as blood, from a patient injection siteinto an IV tube or catheter. After the fluid has been drawn into the IVtube, the fluid sampling device can be introduced into a sample port ofthe IV tube to retrieve a sample of the bodily fluid. After a fluidsample has been retrieved, the fluid sample can be analyzed with ananalysis device, such as a glucometer, that can be configured toaccommodate the test strip and/or the fluid sampling device.

The fluid sampling system of the present invention can provide a safemethod of obtaining a sample of bodily fluid from a patient. Forinstance, the fluid sampling system can reduce the need to use needleseach time a blood sample is needed, which in turn can reduce the painand discomfort a patient experiences each time he or she is pricked.Further, the possibility that a healthcare worker will be pricked with acontaminated needle can be reduced with use of the fluid samplingsystem. Additionally, the fluid sampling system can be simple to use,thus allowing healthcare workers to focus on other aspect of thepatient's treatment.

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter.

Additional features and advantages will be set forth in the descriptionwhich follows, and in part will be obvious from the description, or maybe learned by the practice of the teachings herein. Features andadvantages of the invention may be realized and obtained by means of theinstruments and combinations particularly pointed out in the appendedclaims. Features of the present invention will become more fullyapparent from the following description and appended claims, or may belearned by the practice of the invention as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent invention, a more particular description of the invention willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the invention and aretherefore not to be considered limiting of its scope. The invention willbe described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 illustrates a fluid sampling system according to one embodimentof the present invention;

FIG. 2 illustrates a perspective view of a fluid sampling deviceaccording to an exemplary embodiment of the present invention;

FIG. 3 illustrates an end view of a test strip housing portion of thefluid sampling device of FIG. 2;

FIG. 4 illustrates an exemplary fluid sampling device according to thepresent invention associated with a glucometer for analyzing a fluidsample obtained with the fluid sampling device;

FIG. 5A illustrates a perspective view of another embodiment of thefluid sampling device of the present invention, the fluid samplingdevice being associated with a glucometer;

FIG. 5B illustrates a perspective view of yet another embodiment of thefluid sampling device of the present invention, the fluid samplingdevice being associated with a glucometer;

FIG. 6A illustrates a perspective view of the fluid sampling device ofFIG. 2 associated with a glucometer having a receptacle for receivingthe fluid sampling device and an ejector for removing the fluid samplingdevice;

FIG. 6B illustrates an end view of the glucometer of FIG. 6A; and

FIG. 6C illustrates a perspective view of the glucometer of FIG. 6Aejecting a fluid sampling device therefrom.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Embodiments of the present invention described herein relate to a fluidsampling system. The fluid sampling system can include a fluid drawingdevice, a fluid sampling device, and a glucometer to analyze the fluidsample. Other standard medical equipment used in conjunction with theseelements can include a pressure transducer, an IV stand, a pressure bag,saline solution, IV tubing, and a vascular access, such as an IV,Arterial Line, or a Central Venous Line, for example.

The fluid drawing device of the fluid sampling system can be used todraw bodily fluid, such as blood, from a patient injection site into anIV tube or catheter. After the fluid has been drawn into the IV tube,the fluid sampling device can be introduced into a sample port of the IVtube to retrieve a sample of the bodily fluid. After a fluid sample hasbeen retrieved, the fluid sample can be analyzed with an analysisdevice, such as a glucometer, that can be configured to accommodate thetest strip and/or the fluid sampling device.

The fluid sampling system of the present invention can provide a safemethod of obtaining a sample of bodily fluid from a patient. Forinstance, the fluid sampling system can reduce the need to use needleseach time a blood sample is needed, which in turn can reduce the painand discomfort a patient experiences each time he or she is pricked.Further, the possibility that a healthcare worker will be pricked with acontaminated needle can be reduced with use of the fluid samplingsystem. Additionally, the fluid sampling system can be simple to use,thus allowing healthcare workers to focus on other aspect of thepatient's treatment.

In the disclosure, reference is made to the use of a test strip with afluid sampling device. As used in the disclosure and the claims, a teststrip can be any device capable of detecting attributes of a fluidsample. By way of example and not limitation, a test strip can comprisea substrate with an absorbent material and a reagent disposed thereon.Alternatively, a test strip can comprise electrical leads or connectionswhich can communicate various properties of a fluid sample to ananalysis device, such as a glucometer. It will be appreciated that atest strip can also comprise a combination of any one or more of areagent, an absorbent material, and electrical connections. Whilereference to specific types of test strips is made herein, it will beappreciated that the specific test strips referred to are providedmerely as examples and it is contemplated that the present invention canutilized or adapted for use with other types of test strips notspecifically referred to herein. For example, a test strip having anabsorbent material and/or a reagent can be replaced with a test striphaving electrical connections.

In the disclosure, reference is also made to IV tubes used with thefluid sampling system. As used in the disclosure and claims, an IV tubecan include, but is not limited to, a central line, a PICC line, afeeding tube, a drain tube, or nearly any type of fluid pathway orcatheter, including urinary, pulmonary artery, or cardiac catheters.

In one example embodiment, an IV tube is connected to a pressure bag (ora pressure transducer) at one end thereof, while the other end of the IVtube is in fluid communication with a patient injection site. A fluiddrawing device can be connected the IV tube between the pressure bag andthe patient such that fluid flowing through the IV tube also flowsthrough the fluid drawing device or is otherwise in fluid communicationwith the fluid drawing device. In addition, the IV tube also includes asample port between the fluid drawing device and the patient. The fluidsampling device can be inserted into the sample port in order to take asample of the fluid in the IV tube.

When the fluid sampling system is configured as described above, a user,such as a doctor or nurse, can take a sample of a patient's bodilyfluid, such as blood, by activating the fluid drawing device, whichdraws the bodily fluid into the IV tube past the sample port. The usercan then insert the fluid sampling device into the sample port toretrieve a sample of the bodily fluid. When a sufficient fluid samplehas been retrieved, the fluid sampling device can be removed from thesample port. The fluid sampling device can be configured to have a teststrip disposed therein. When the bodily fluid enters the fluid samplingdevice from the sample port, the bodily fluid can be absorbed by or comeinto contact with the test strip. The sample of bodily fluid can then beanalyzed by an analysis device, such as a glucometer.

As seen in FIG. 1, an exemplary embodiment of the fluid sampling system100 can include an IV tube 102, a fluid drawing device 104, a sampleport 106, and a fluid sampling device 110. Fluid drawing device 104 isin fluid communication with IV tube 102 such that fluid drawing device104 can draw fluid from a patient through IV tube 102 past sample port106. After fluid drawing device 104 has drawn fluid past sample port106, fluid sampling device 110 can be introduced into sample port 106 toobtain a fluid sample, as illustrated by the dotted lines shown in FIG.1.

FIG. 1 illustrates an exemplary embodiment of a fluid drawing device104, details of which are disclosed in co-pending U.S. patentapplication Ser. No. 11/765,888, entitled SYSTEMS, METHODS, AND DEVICESFOR SAMPLING BODILY FLUID, which is incorporated herein by reference. Itwill be appreciated, however, that any device capable of drawing fluidthrough IV tube 102 past sample port 106 may be used in place of theillustrated fluid drawing device 104. For example, a syringe connectedto IV tube 102 can be used to draw fluid from a patient into IV tube102. Similarly, a VAMP® system made by Edwards Lifesciences Corporationcan be used to draw fluid from a patient into IV tube 102.

In use, fluid drawing device 104 is connected to IV tube 102 such thatfluid drawing device 104, when activated, is able to draw a patient'sbodily fluid through IV tube 102 past sample port 106. The drawing offluid through IV tube 102 can be accomplished in a variety of ways. Forexample, when fluid drawing device 104 is activated, a negative pressurecan be created within IV tube 102. The negative pressure is sufficientto draw the fluid, such as blood, from a patient into IV tube 102 andpast sample port 106. After the bodily fluid has been drawn past sampleport 106, the user can then insert fluid sampling device 110 into sampleport 106 to retrieve the desired fluid sample.

FIGS. 2 and 3 illustrate perspective views of an embodiment of fluidsampling device 110. Fluid sampling device 110 comprises a test strip112 and a test strip adapter 114. Test strip adapter 114 includes ablunt canula 116 and a test strip housing 118. As illustrated in FIGS. 2and 3, test strip housing 118 has a generally flat, rectangular shapewith a test strip receptacle 120. Test strip receptacle 120 is adaptedto receive an end of test strip 112 therein. In the illustratedembodiment, test strip receptacle 120 is sized and configured togenerally correspond to the size and shape of test strip 112 such thatan end of test strip 112 can be inserted and maintained within teststrip receptacle 120. Test strip 112 can be held within test stripreceptacle 120 of test strip housing 118 by a variety of means,including frictional coupling, mechanical fasteners such as clamps orpins, and adhesives such as glue. Test strip housing 120, test stripreceptacle 118, friction couplings, mechanical fasteners, and adhesivesare each examples of means for holding a test strip. In addition, teststrip housing 118 can function as a handle to facilitate simple andconvenient use of fluid sampling device 110.

As can be seen in FIG. 2, the walls of test strip receptacle 120 includegrooves 122 which are adapted to assist in venting air from test strip112 and test strip receptacle 120 to enable fluid to readily flow intotest strip receptacle 120 and/or be absorbed by test strip 112. Grooves122 are one example of means for venting air from test strip housing 118and test strip receptacle 120. Additionally, grooves 122 can be adaptedto assist in properly aligning test strip 112 when it is being insertedinto test strip receptacle 120. Furthermore, grooves 122 can also assistin holding test strip 112 within test strip receptacle 120. Thus,grooves 122 are one example of means for holding test strip 112.

In the exemplary embodiment, grooves 122 extend from the opening of teststrip receptacle 120 to about the opposing end of test strip receptacle120. As illustrated, the opposing end of grooves 122 can include anabutment 132. Abutment 132 can be a means for ensuring properpositioning of test strip 112 within test strip receptacle 120. Forexample, as test strip 112 is inserted into test strip receptacle 120,abutment 132 can prevent over insertion as well as provide a tactileindication that test strip 112 has been fully inserted. It will beappreciated that grooves 122 can be configured in ways other than thoseillustrated. For example, grooves 122 can comprise a single groove ormultiple grooves, and the size, shape, orientation and positioning ofgrooves 122 can be altered based, for example, on the type of test stripused with test strip adapter 114.

Test strip 112 can be any one of a variety of test strips havingelectrical connections 120 or other means for detecting, analyzingand/or conveying properties of a fluid sample received by fluid samplingdevice 110. For example, test strip 112 could be a ONE TOUCH ULTRA® teststrip made by LifeScan (a Johnson & Johnson subsidiary) or a COMFORTCURVE® test strip made by Accu-Chek (a Roche subsidiary). It will beappreciated that test strip 112 is not limited to the above-identifiedtest strips. For example, test strip 112 can comprise an absorbentmaterial, a reagent, and/or electrical leads that are not mounted on asubstrate, but which can detect, convey, and/or analyze properties of afluid sample. Thus, means for detecting, conveying, or analyzing aproperty of a fluid sample can include any one or more of electricalleads, an absorbent material, and a reagent.

Extending from an end of test strip housing 118 is a tapered portion124. Tapered portion 124 is generally funnel shaped and connects teststrip housing 118 to blunt canula 116. Blunt canula 116 has a lumen 126extending from a distal end of blunt canula 116 to the interior 128 oftapered portion 124 in order to communicate a fluid sample through teststrip adapter 114. Blunt canula 116, lumen 126, tapered portion 124, andinterior 128 are each examples of means for communicating a fluid. Thedistal end of blunt canula 116 is adapted to be inserted into sampleport 106 (FIG. 1) to obtain a fluid sample, such as a blood sample.Blunt canula 116 is one example of means for accessing an interiorportion of a sample port to obtain a fluid sample.

Fluid sampling device 110 can be made from medical device industrystandard plastics including, but not limited to thermoplastics, such asPolyethylene (PE), High Density Polyethylene (HDPE), Polypropylene (PP),Polystyrene (PF), Polyethylene Terephthalate (PET), and acrylic (fortransparent properties), because of their low cost production, abilityto be easily molded, sterility, and strength.

Fluid sampling device 110 can be formed of multiple discrete parts thatare coupled together. For example, test strip housing 118, taperedportion 124, and blunt canula 116 can be made from discrete parts andjoined together, such as with an adhesive. Alternatively, fluid sampledevice 110 can be formed as a single integral piece through a moldingprocess, for example. Additionally, a fluid monitoring device, such asan absorbent material or electrical connections, can be at leastpartially disposed within or in fluid communication with the test stripreceptacle 120 such that various attributes of the fluid sample can bedetected without the use of a conventional test strip.

In use, test strip 112 is positioned within test strip receptacle 120 offluid sampling device 110. After fluid drawing device 104 has beenactivated and a fluid has been drawn into IV tube 102 past sample port106, a user can insert the distal end of blunt canula 116 into sampleport 106 to obtain a fluid sample. Pressure, such as hydrostatic,hemodynamic, or mechanically induced pressure, causes fluid from sampleport 106 to enter lumen 126, move up through blunt canula 116 andtapered portion 124, and onto test strip 112. As noted, grooves 122 aredisposed adjacent test strip 112 to facilitate the escape of air fromtest strip 112 and test strip receptacle 120, thus enabling the fluidsample to readily flow into test strip receptacle 120 and onto teststrip 112.

When a sufficient fluid sample has been obtained, fluid sampling device110 can be removed from sample port 106. Electrical connections 130 oftest strip 112 can then be inserted into a glucometer, such asglucometer 200 illustrated in FIG. 4, for analysis. The electricalconnections 130 of test strip 112 can be inserted in glucometer 200after the fluid sample has been obtained. Alternatively, test strip 112can be inserted into glucometer 200 prior to inserting blunt canula 116into sample port 106. In this manner, the fluid sample can be obtainedand glucometer 200 can begin to analyze the sample immediately, withoutthe intervening step of inserting the test strip 112 into glucometer 200after obtaining the fluid sample.

Glucometers, such as the one illustrated in FIG. 4, are well known inthe art. A typical glucometer 200 comprises a housing 202, keys 204,display 206, internal analysis apparatus (not shown), and a receptacle208 for receiving a test strip having a fluid sample, such as a bloodsample, disposed thereon. The glucometer shown in FIG. 4 has areceptacle 208 that is designed to receive an end of test strip 112therein. Disposed within receptacle 208 are electrical connections (notshown) which are adapted for electrical communication with electricalconnections 130 of test strip 112 when the end of test strip 112 isinserted within receptacle 208. The internal analysis apparatus ofglucometer 200 is adapted to analyze various electrical properties ofthe fluid sample received on test strip 112 and provide the results ondisplay 206. Such electrical properties can include the resistance,impedance, capacitance, and the like of the fluid sample. Glucometer 200is adapted to determine various attributes of the fluid sample, such asthe glucose level of a blood sample, based on the electrical propertiesof the fluid sample. As noted above, fluid sampling system 100 canemploy a glucometer that is adapted to analyze a fluid sample based onnon-electrical properties of the fluid sample, including color changes,luminescence, and the like.

FIGS. 5A and 5B illustrate alternative embodiments of the fluid samplingdevice of the present invention. The fluid sampling device 150 of FIG.5A is similar to fluid sampling device 110. In particular, fluidsampling device 150 includes a test strip adapter 114 that receives atest strip 112 therein. The test strip adapter 114 includes a bluntcanula 116, a test strip housing 118, and a connecting portion 124similar to those of fluid sampling device 110. In addition, fluidsampling device 150 also includes a tab 134 that extends from the end oftest strip housing 118 opposite blunt canula 116. Tab 134 is shaped andsized to extend around at least a portion of glucometer 200 when fluidsampling device 150 is associated with glucometer 200, as illustrated inFIG. 5A.

Tab 134 is adapted to provide greater stability to fluid sampling device150 when fluid sampling device 150 is used to obtain a fluid sample fromsample port 106. When obtaining a fluid sample with fluid samplingdevice 150 when it is associated with glucometer 200 as illustrated,glucometer 200 acts as an enlarged handle for fluid sampling device 150.A user holding glucometer 200 can also hold tab 134 with the same hand,thereby providing greater rigidity and stability between glucometer 200and fluid sampling device 150. Additionally, after the fluid sample hasbeen obtained, tab 134 can be used to remove fluid sampling device 150from glucometer 200. Specifically, a user can simply push on tab 134 inthe direction of blunt canula 116 to disengage fluid sampling device 150from glucometer 200.

FIG. 5B illustrates an alternative embodiment of stabilizing tab 134. Inparticular, tab 136 of FIG. 5B extends from fluid sampling device 160and is larger than tab 134 of FIG. 5A. Tab 136 extends further aroundthe sides of glucometer 200. Tab 136 can provide even greater rigidityand stability between fluid sampling device 160 and glucometer 200.

FIG. 5B also illustrates blunt canula 116 having a one-way valve 138 toprevent or limit the reflux of air into IV tube 102. In the illustratedembodiment, the valve 138 is coupled to the distal end of lumen 126. Thevalve 138 can also be disposed in other positions within lumen 126.One-way valves suitable for such medical devices are well known in theart. Valve 138 can be made of a medical grade plastic and/or rubber.

Attention is now directed to FIGS. 6A-6C, in which is illustrated amodified glucometer 210 for use with test strip adapter 110. Similar toglucometer 200, glucometer 210 includes a housing 202, keys 204, display206, internal analysis apparatus (not shown), and a receptacle 208 forreceiving a test strip therein. Disposed within receptacle 208 areelectrical connections (not shown) which are adapted for electricalcommunication with electrical connections 130 of test strip 112 when theend of test strip 112 is inserted within receptacle 208. The internalanalysis apparatus of glucometer 210 is adapted to analyze variouselectrical properties of the fluid sample received on test strip 112 andprovide the results on display 206. Such electrical properties caninclude the resistance, impedance, capacitance, and the like of thefluid sample. Glucometer 210 is adapted to determine various attributesof the fluid sample, such as the glucose level of a blood sample, basedon the electrical properties of the fluid sample. As noted above, fluidsampling system 100 can employ a glucometer that is adapted to analyze afluid sample based on non-electrical properties of the fluid sample,including color changes, luminescence, and the like.

In addition to the above-identified features, glucometer also includes amechanism for securely coupling together and selectively releasing teststrip adapter 110 and glucometer 210. More specifically, glucometer 210includes a test strip adapter receptacle 212 for receiving an end oftest strip adapter 110 therein. Test strip adapter receptacle 212 isformed adjacent test strip receptacle 208 such that when test stripadapter 110 is positioned within test strip adapter receptacle 212, teststrip 112 can be positioned within both test strip receptacle 208 ofglucometer 210 and test strip receptacle 120 of test strip adapter 110.

As illustrated in FIG. 6B, the interior surface of test strip adapterreceptacle 212 is configured to generally conform to the exteriorsurface shape of test strip adapter 110. The complimentary shapes oftest strip adapter 110 and test strip adapter receptacle 212 facilitatesthe secure engagement of test strip adapter 110 within test stripadapter receptacle 212 during use. More specifically, the shape of teststrip adapter receptacle 212 prevents test strip adapter 110 from movingrelative to glucometer 210 when glucometer 210 and test strip adapter110 are used to obtain a fluid sample. Thus, the configuration of teststrip adapter receptacle 212 is adapted to maintain a desiredorientation of test strip adapter 110 relative to glucometer 210.

Test strip adapter receptacle 212 is formed by housing 202 and anejector 214. In the illustrated embodiment, housing 202 forms the lowerhalf of test strip adapter receptacle 212, while ejector 214 forms theupper half of test strip adapter receptacle 212. Housing 202 and ejector214 also cooperate to form channels 216 on opposing sides of test stripadapter receptacle 212. Channels 216, similar to grooves 122 describedabove, assist in venting air from test strip 112, test strip receptacle120, and test strip adapter receptacle 212 to enable fluid to readilyflow into test strip receptacle 120 and/or test strip 112. Grooves 216are, therefore, one example of means for venting air from test striphousing 118 and test strip receptacle 120.

In addition to assisting in maintaining the position and orientation oftest strip adapter 110 within test strip adapter receptacle 212, ejector214 also facilitates removal of test strip adapter 110 and/or test strip112 from glucometer 210. Ejector 214 is movably coupled to housing 202of glucometer 210. As illustrated in FIG. 6C, ejector 214 can beslidably or otherwise coupled to housing 202 such that ejector 214 canmove relative to housing 202 in a direction generally parallel to alongitudinal axis of housing 202.

When ejector 214 is in a receiving position as illustrated in FIG. 6A,test strip adapter 110 can be inserted and maintained within test stripadapter receptacle 212 as described herein. As noted, ejector 214 can bemoved relative to housing 202 as illustrated in FIG. 6C. By movingejector 214 as shown in FIG. 6C, test strip adapter 110 is made readilyremovable from test strip adapter receptacle 212. In particular, ejector214 includes a ridge 218 that engages a rear surface of test stripadapter 110. As ejector 214 is moved to the position shown in FIG. 6C,ridge 218 pushes against the rear surface of test strip adapter 110,thereby pushing test strip adapter in the same direction that ejector214 is moving.

Ejector 214 can be configured to completely remove test strip adapter110 from test strip adapter receptacle 212 without requiring a user totouch test strip adapter 110. In particular, a user simply moves ejector214 to the position shown in FIG. 6C, at which point test strip adapter110 would no longer be within test strip adapter receptacle 212 and teststrip adapter 110 would disengage from glucometer 210. Alternatively,ejector 214 can be adapted to partially remove test strip adapter 110from test strip adapter receptacle 212. For example, a user could moveejector 214 to the position shown in FIG. 6C, which would slide teststrip adapter 110 out of test strip adapter receptacle 212 far enoughthat a user could easily remove test strip adapter 110 from glucometer210.

Ejector 214 can be biased towards the receiving position illustrated inFIG. 6A. In particular, ejector 214 can be biased such that prior toinserting test strip adapter 110 into test strip adapter receptacle 212,ejector 214 is held in the receiving position illustrated in FIG. 1 sothat test strip adapter 110 can be inserted into test strip adapterreceptacle 212 as described above. Similarly, after obtaining a fluidsample and removing test strip adapter 110 using ejector 214, ejector214 can be biased back toward the receiving position shown in FIG. 6A.Ejector 214 can be biased with any suitable biasing means, includingsprings such as coil springs, leaf springs, and the like.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

1. A test strip adapter configured to convey a fluid sample from asample port associated with a patient's blood stream directly to a teststrip associated with said test strip adapter, the test strip adaptercomprising: a test strip housing adapted to receive a portion of thetest strip therein, the size and shape of said test strip housinggenerally corresponding to the size and shape of the test strip portionreceived within said test strip housing; a blunt canula extending fromsaid test strip housing, said blunt canula having a lumen extendingtherethrough, said lumen and said test strip housing being in fluidcommunication with one another to enable a fluid to flow therethrough tocommunicate a fluid to the test strip.
 2. The test strip adapter ofclaim 1, further comprising means for venting air from said test striphousing.
 3. The test strip adapter of claim 2, wherein said means forventing air comprises a groove disposed within an interior wall of saidtest strip housing.
 4. The test strip adapter of claim 3, wherein saidgroove comprises an abutment portion that facilitates proper positioningof a test strip within said test strip housing.
 5. The test stripadapter of claim 2, wherein said means for venting air comprises aplurality of grooves disposed within one or more interior walls of saidtest strip housing.
 6. The test strip adapter of claim 1, wherein saidblunt canula is adapted to be received within a sample port.
 7. A teststrip adapter configured to convey a fluid sample from a sample portassociated with a patient's blood stream directly to a test stripassociated with the test strip adapter, the test strip adaptercomprising: means for holding a test strip, wherein said means forholding substantially encloses a first end of the test strip thereinwhile allowing a second end of the test strip to extend out of saidmeans for holding a test strip, thereby exposing said second end,wherein said second end of said test strip is adapted to be insertedinto an analysis device; means for accessing an interior of a sampleport; and means for communicating a fluid to the test strip, whereinsaid means for communicating extends from said means for holding.
 8. Thetest strip adapter of claim 7, wherein said means for holding a teststrip comprises a plurality of grooves.
 9. The test strip adapter ofclaim 7, where said means for holding comprises a test strip housinghaving an interior portion configured to receive a portion of the teststrip therein, wherein said interior portion is sized and shaped togenerally corresponding to the size and shape of the test strip portionreceived within said interior portion of said test strip housing. 10.The test strip adapter of claim 7, wherein said means for accessing aninterior of a sample port comprises a blunt canula.
 11. The test stripadapter of claim 7, wherein said means for communicating a fluidcomprises a lumen extending through said means for accessing.
 12. Thetest strip adapter of claim 11, wherein said lumen is in fluidcommunication with said means for holding a test strip.
 13. A fluidsampling device configured to obtain a fluid sample from a sample portassociated with a patient and directly convey information about thefluid sample to an analysis device associated with the fluid samplingdevice, the fluid sampling device comprising: a test strip adapted toreceive a fluid sample and convey at least one property of the fluidsample to the analysis device; and a test strip adapter configured toreceive a first portion of said test strip therein while allowing asecond portion of said test strip to extend out of said test stripadapter for association with the analysis device, said test stripadapter being configured to transfer a fluid sample directly from thesample port to said test strip, said test strip adapter comprising meansfor venting air from said test strip adapter.
 14. The fluid samplingdevice of claim 13, wherein said test strip comprises electrical leads,an absorbent material, a reagent, or a combination thereof.
 15. Thefluid sampling device of claim 13, where said test strip adaptercomprises means for conveying a fluid from a sample port to said teststrip.
 16. The fluid sampling device of claim 15, wherein said means forconveying comprises a blunt canula.
 17. The fluid sampling device ofclaim 16, wherein said blunt canula comprises a lumen extendingtherethrough.
 18. The fluid sampling device of claim 16, wherein saidmeans for conveying further comprises a tapered portion extending fromsaid blunt canula, said tapered portion having an interior through whicha fluid can pass.
 19. The fluid sampling device of claim 13, whereinsaid test strip adapter comprises a test strip housing having a teststrip receptacle for receiving said first portion of said test striptherein.
 20. The fluid sampling device of claim 19, wherein said teststrip is secured within said test strip receptacle.
 21. The fluidsampling device of claim 19, wherein said test strip is selectivelyremovable from within said test strip receptacle.
 22. The fluid samplingdevice of claim 13, wherein said test strip adapter is configured to beinserted into the sample port to access a fluid supply, and wherein saidtest strip adapter is configured to convey a fluid from the sample portto said test strip while said test strip adapter is inserted in saidsample port.
 23. A fluid sampling device configured to obtain a fluidsample from a sample port associated with a patient and directly conveyinformation about the fluid sample to an analysis device associated withthe fluid sampling device, the fluid sampling device comprising: meansfor detecting at least one property of the fluid sample; means forconveying the at least one property to the analysis device; and meansfor communicating a fluid sample directly from the sample port to saidmeans for detecting while said means for communicating is simultaneouslyassociated with the sample port and said means for detecting.
 24. Thefluid sampling device of claim 23, wherein said means for detectingcomprises electrical leads, an absorbent material, a reagent, or acombination thereof.
 25. The fluid sampling device of claim 24, whereinsaid electrical leads are adapted to detect a resistance, impedance, orcapacitance of the fluid sample.
 26. The fluid sampling device of claim23, wherein said means for conveying comprises electrical leads adaptedto communicate the at least one property of the fluid sample to theanalysis device.
 27. The fluid sampling device of claim 23, wherein saidmeans for detecting are at least partially disposed within a housing.28. The fluid sampling device of claim 23, wherein said means fordetecting and means for conveying comprise the same means.
 29. The fluidsampling device of claim 23, wherein said means for communicatingcomprises a lumen extending through a blunt canula.
 30. The fluidsampling device of claim 23, wherein said means for detecting can beselectively associated with said means for communicating.
 31. A fluidsampling system configured to receive a fluid sample from a patient anddirectly convey information about the fluid sample to an analysisdevice, the fluid sampling system comprising: an intravenous tube influid communication with a patient's blood stream, the intravenous tubecomprising a sample port; a test strip adapted to i) detect at least oneproperty of a fluid sample received by said test strip, and ii) conveythe at least one property of the fluid sample to the analysis device;and a test strip adapter associated with said test strip, said teststrip adapter being configured to transfer the fluid sample from saidsample port directly to said test strip while said test strip isassociated with said test strip adapter and said test strip adapter isassociated with said sample port, said test strip adapter comprising: atest strip housing having a first end and a second end, said first endof said test strip housing being adapted to receive a first end of saidtest strip therein, wherein the size and shape of said first end of saidtest strip housing generally corresponds to the size and shape of saidfirst end of said test strip; and a blunt canula extending from saidsecond end of said test strip housing, said blunt canula having a lumenextending therethrough for communicating fluid from said sample port tosaid first end of said test strip.
 32. The fluid sampling system ofclaim 31, wherein said test strip housing further comprises a grooveadapted to assist in venting air from said test strip to enable saidtest strip to ready receive the fluid sample.
 33. The fluid samplingsystem of claim 31, wherein a longitudinal axis of said blunt canula isgenerally parallel to a longitudinal axis of said test strip housing.34. The fluid sampling system of claim 31, further comprising a fluiddrawing device associated with said intravenous tube, said fluid drawingdevice being adapted to draw a fluid from a patient to said sample port.35. The fluid sampling system of claim 34, wherein the fluid drawingdevice is adapted to create a negative pressure within said intravenoustube to draw the fluid from the patient.
 36. The fluid sampling systemof claim 31, further comprising an analysis device for analyzing the atleast one property of the fluid sample, wherein said analysis device isadapted to receive said second end of said test strip while said firstend of said test strip is positioned within said test strip housing. 37.The fluid sampling system of claim 36, wherein said analysis devicecomprises a glucometer.
 38. The fluid sampling system of claim 36,wherein said analysis device is adapted to analyze at least one of aresistance, an impedance, a capacitance, a luminescence, or a colorchange of the fluid sample.
 39. A fluid sampling system configured toreceive a fluid sample from a patient and directly convey informationabout the fluid sample to an analysis device, the fluid sampling systemcomprising: an intravenous tube in fluid communication with a patient'sblood stream, the intravenous tube comprising a sample port; a teststrip adapted to detect at least one property of a fluid sample obtainedthrough said sample port and convey the at least one property to theanalysis device; and a test strip adapter having a first end and asecond end, said first end being configured to receive a first portionof said test strip therein while allowing a second portion of said teststrip to extend out of said test strip adapter, said second end of saidtest strip adapter being configured to be inserted into said sampleport, said test strip adapter being configured to communicate a fluidsample from said sample port directly to said test strip while saidfirst portion of said test strip is within said first end of said teststrip adapter and said second end of said test strip adapter is insertedwith said sample port, and an analysis device configured to receive saidsecond portion of said test therein while said first portion of saidtest strip is within said first end of said test strip adapter, whereinsaid analysis device is adapted to analyze the at least one detectedproperty of the fluid sample.
 40. The fluid sampling system of claim 39,wherein said test strip adapter comprises: a test strip housing havingadapted to receive said first portion of said test strip therein; and ablunt canula extending from said second end of said test strip housing,said blunt canula having a lumen extending therethrough forcommunicating fluid from said sample port to said test strip.
 41. Thefluid sampling system of claim 39, wherein said test strip is adapted tobe simultaneously inserted within said analysis device and said teststrip adapter, and wherein said second end of said test strip adapter isadapted to be inserted within said sample port while said test strip issimultaneously inserted within said analysis device and said test stripadapter.
 42. A method for sampling and analyzing a bodily fluid,comprising: inserting a first end of a test strip into a first end of atest strip adapter; inserting a second end of the test strip adapterinto a sample port that is in fluid communication with a patient'sbodily fluid to obtain a fluid sample, wherein the test strip adaptercomprises a fluid pathway for communicating the fluid sample to the teststrip; and inserting a second end of the test strip into an analysisdevice while the first end of the test strip is positioned in the teststrip adapter.
 43. The method of claim 42, further comprising detectingat least one property of said fluid sample.
 44. The method of claim 43,wherein the at least one property of the fluid sample comprises anelectrical property of the fluid sample.
 45. The method of claim 43,further comprising analyzing the at least one property of the fluidsample.
 46. The method of claim 42, further comprising drawing thebodily fluid into the sample port prior to inserting the second end ofthe test strip adapter into the sample port.
 47. A method for samplingand analyzing a bodily fluid, comprising: inserting a first end of atest strip into an analysis device; inserting a second end of the teststrip into a first end of a test strip adapter; inserting a second endof the test strip adapter into a sample port that is in fluidcommunication with a patient's bodily fluid to obtain a fluid sample;communicating the fluid sample through the test strip adapter to thetest strip; and communicating at least one property of the fluid samplefrom the test strip to the analysis device.
 48. The method of claim 47,further comprising detecting the at least one property of the fluidsample prior to communicating the at least one property to the analysisdevice.
 49. The method of claim 47, wherein the analysis devicecomprises a glucometer.
 50. The method of claim 49, further comprisingremoving the second end of the test strip adapter from the sample portonce the fluid sample has been obtained.